Steinberg 2002.
| Methods | RCT Protocol approved by the ethics committee at each of the 5 centres and informed written consent obtained Setting: United States of America Funding: industry |
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| Participants | ASA physical status classification 4, age 18 to 80 years, weight 50 to 110 kg patients undergoing elective partial colon resection at 5 institutions | |
| Interventions |
Treatment group: TEA ( T7‐T10; PCEA with catheter inserted 3 to 5 cm cephalad) with ropivacaine 0.2% and fentanyl 2 mcg/mL adjusted for resting VAS scores < 5/10 until the predetermined discharge criterion of adequate pain control with oral medication was met, or a maximum of 6 days (n = 20) Control group: IV PCA with morphine (n = 21) General anaesthesia for all participants. Ketorolac was given intramuscularly or IV to both groups as a supplementary analgesic. Treatment for relief of nausea or vomiting was administered at the discretion of the investigator |
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| Outcomes | Time to first flatus Time to first bowel movement Vomiting (first 24 hours) |
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| Notes | Because of the slow accrual of participants, study was terminated before enrolment of the desired 120 participants Time to achieved discharge milestones approximately 1 day sooner than in the IV PCA group (P value < 0.002). Standardized criteria required that participants be afebrile (T 37.7°C), able to ingest sufficient fluid PO to maintain hydration, maintain adequate pain control with oral medications and achieve recovery from ileus (passage of flatus). Participants were assessed twice daily, usually concurrently with ambulation and pain assessments, for completion of discharge criteria Study authors contacted for additional information on 22 July 2014; referred us to AstraZeneca, which did not reply |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomized", no details |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "open" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | "open" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 48 participants were randomized to the study, and 41 completed the protocol |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Unclear risk | Groups well balanced Supported by a grant from AstraZeneca LP, Sodertalje, Sweden Not in intention‐to‐treat |